Arzerra (ofatumumab) is a monoclonal antibody that affects the actions of the body"s immune system. Monoclonal antibodies are made to target and destroy only certain cells in the body. This may help to protect healthy cells from damage.
Arzerra is used to treat chronic lymphocytic leukemia.
Arzerra is usually given after other medications have been tried without success.
Arzerra may also be used for purposes not listed in this medication guide.
Important information
Arzerra increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines. Call your doctor right away if you have symptoms such as change in your mental state, problems with speech or walking, or decreased vision. These symptoms may start gradually and get worse quickly.
Before you receive Arzerra, tell your doctor if you have hepatitis or severe COPD.
To be sure Arzerra is not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested for several months, even after you stop using it. Do not miss any follow-up visits to your doctor.
If you have certain risk factors for hepatitis B, Arzerra can cause this condition to come back or get worse, which could lead to liver failure or death. You will need frequent blood tests to check your liver function.
Arzerra may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, or problems with speech or walking.
Before receiving Arzerra
Arzerra increases the risk of a serious viral infection of the brain that can lead to disability or death. This risk is higher if you have a weak immune system or are receiving certain medicines.
To make sure Arzerra is safe for you, tell your doctor if you have:
If you have certain risk factors for hepatitis B, the virus could become active again while you are using Arzerra and for up to several months after you stop using it. This has resulted in liver failure or death in some people using Arzerra. Your doctor will perform blood tests to make sure you do not have conditions that may cause you to develop hepatitis B.
FDA pregnancy category C. It is not known whether Arzerra will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.
See also: Pregnancy and breastfeeding warnings (in more detail)
It is not known whether ofatumumab passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How is Arzerra given?
Arzerra is injected into a vein through an IV. A healthcare provider will give you this injection. The medicine must be given slowly through an IV infusion, and one dose can take up to several hours to complete.
Arzerra is usually given in a series of 12 doses. The first 8 doses are given 1 week apart. The last 4 doses are given 4 weeks apart. You may also need to take antiviral medications if you are found to have any risk factors for hepatitis B. Follow your doctor"s dosing instructions very carefully.
You will be given other IV or oral (by mouth) medications to prevent certain side effects of Arzerra. You may need to start using these medications up to 2 hours before the start of your Arzerra infusion.
Arzerra can have long lasting effects on your body. You may also need frequent medical tests while you are using this medicine and for a short time after you stop using this medication.
If you have hepatitis B you may develop liver symptoms after you stop taking this medication, even months after stopping. Your doctor may want to check your liver function for several months after you stop using Arzerra.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Arzerra injection.
What happens if I overdose?
Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid?
Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.
Do not receive a "live" vaccine while using Arzerra. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.
Arzerra side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Arzerra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, nauseated, light-headed, confused, itchy, tingly, or have chest pain, jaw or arm pain, back pain, stomach pain, wheezing, chest tightness, or trouble breathing. These reactions can occur during the injection or within 24 hours afterward.
Call your doctor at once if you have:
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change in your mental state, problems with speech or walking, decreased vision (these symptoms may start gradually and get worse quickly);
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fever, chills, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms;
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stabbing chest pain, wheezing, feeling short of breath, cough with yellow or green mucus;
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liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
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signs of tumor cell breakdown--lower back pain, blood in your urine, little or no urinating; numbness or tingly feeling around your mouth; muscle weakness or tightness; fast or slow heart rate, weak pulse, feeling short of breath; confusion, fainting.
Common Arzerra side effects may include:
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect Arzerra?
Other drugs may interact with Arzerra, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
